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On any given day, more than 700,000 people in the United States receive alcoholism treatment in either inpatient or outpatient settings. For many of those patients, detoxification--with or without pharmacotherapy--is the first step of treatment. The major behavioral approaches currently used in alcoholism treatment include cognitive-behavioral therapy, motivational enhancement therapy, and Alcoholics Anonymous (AA) or related 12-step programs. Clinical studies, such as the Project MATCH trial, have compared the effectiveness of these approaches. Overall, that study detected no significant differences among the three treatments in patient outcome, although certain treatment methodologies may be most appropriate for patients with certain characteristics. Pharmacotherapy with aversive or anticraving medications may supplement behavioral treatment approaches. Brief interventions that are delivered by primary health care providers also have been shown to reduce drinking levels, particularly in nondependent drinkers.

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This paper considers an index to assess the success of blinding with application to a clinical trial of disulfiram. The index increases as the success of blinding increases, accounts for uncertain responses, and is scaled to an interval of 0.0 to 1.0, 0.0 being complete lack of blinding and 1.0 being complete blinding.

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Although older individuals drink less and report fewer alcohol-related problems than do younger individuals, alcohol use and abuse are significant health issues for older patients. The signs and symptoms of alcohol problems and dependence in the elderly may not only differ from those of young problem drinkers, but may also be present at lower levels of alcohol consumption. Older alcoholics do well in alcohol treatment. Therefore, discussion of alcohol consumption is a critical part of every history and physical examination for all patients, including older individuals.

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This article reviews methodological and conceptual issues regarding the choice of drinking outcome measures in alcoholism treatment research. The following issues are discussed: Should drinking outcomes be conceptualized in terms of an underlying unitary disorder, or should provision be made for independent outcomes that cover a wide variety of dimensions? Which drinking outcomes are typically measured in treatment evaluation studies and how are they operationalized? What are the empirical associations among drinking outcome measures? If multiple outcomes are measured, which should be given primary importance? Over what period of time should treatment outcome be evaluated? What procedures can be used to detect, correct or prevent the response bias associated with verbal report methods? Because outcome measures need to fit the hypotheses and practical needs of a particular study, it is unlikely that complete standardization can be achieved across all studies. Nevertheless, given the importance of drinking outcomes and the need for economy, two primary dependent measures are recommended: (1) proportion of available drinking days abstinent; and (2) intensity of drinking, as defined by the total amount consumed (in ounces absolute alcohol) during the follow-up period divided by the number of actual drinking days. This article also proposes a strategy that may help to guide the selection of outcome measures in future research.

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Multisite clinical trials have two major advantages over single-site studies: the large sample size of multisite studies allows for adequate statistical power and better representativeness of the population being studied. However, they are more complex to implement than single-site studies. This article reviews previous multisite clinical trials of alcohol abuse and alcoholism, reasons for selecting a multisite design, management of such studies, and some statistical issues.

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Treatment outcome research consists of two types: controlled clinical trials and in-house program evaluations. Controlled clinical trials are experimental studies designed to test whether or not a treatment is efficacious. In-house program evaluations provide information about the results (outcome) of an individual treatment program. The key components of clinical trials include control groups; randomization procedures; enumeration of those who were screened for inclusion in, those accepted into, and those excluded from the study; a description of the relevant patient characteristics of the sample studied; "double-blinding" for pharmacological studies; raters of treatment effects who are not the therapists for verbal therapies; objective measures of treatment response; follow-up of at least 70% of the original sample; and appropriate statistical analysis of the data collected. In-house program evaluations rarely have control groups or employ randomization. However, a description of the type of patients treated by the program, independent raters, and adequate follow-up of those entering treatment are essential for program evaluation; and the credibility of program evaluation would be enhanced by the use of objective measures of treatment response.

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Carnitine is essential for the beta-oxidation of long-chain fatty acids in the mitochondria and probably has a major role in modulating the acyl-coenzyme A/reduced coenzyme A ratio in the matrix of mitochondria. Plasma carnitine concentrations are elevated in several conditions and reflect changes at the cellular level. We previously had reported elevated plasma carnitine in patients with alcoholic liver disease compared to healthy control subjects. In this study we measured plasma carnitine in a third group, alcoholic patients without overt liver disease. The alcoholic patients (n = 20) had significantly elevated plasma long-chain acylcarnitine (P less than 0.01) compared to 32 healthy men of identical age and significantly lower short-chain (P less than 0.01) and long-chain acylcarnitine (P less than 0.01) than 28 men with alcoholic liver disease. We conclude that alcoholism is another condition in which carnitine homeostasis is altered.

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The validity of self-report in alcoholism treatment research is controversial. Our recently completed Veterans Administration Cooperative Study evaluating the efficacy of disulfiram treatment for alcoholism provided an opportunity to assess the validity of self-report. To assess treatment response, patients and household contacts were interviewed at seven scheduled points during the 1 year of follow-up. Blood specimens also were obtained from the patients at these times and were analyzed for ethanol. Eighty-eight percent of the patient and/or collateral interviews were obtained at 6 months and 90% at 1 year. The mean number of blood and urine specimens collected per patient was 4.3 and 14.4, respectively. Outcome criteria included continuous abstinence during the year and total number of drinking days. Continuous abstinence: If we had had only the patients' self reports, we would have significantly underestimated the percentage of men who drank. By self-report 58.7% (355/605) relapsed whereas the combination of self report, collaterals' reports, and laboratory tests indicated that 72.4% (438/605) drank (p less than 0.001). Using Bayes' theorem, the conditional probability that a patient is continuously abstinent for 1 year when he so claims is 65%. Total drinking days: Of the 213 patient-collateral pairs each of whom provided all seven scheduled interviews, 46.9% (100/213) agreed on the total number of drinking days during the year.(ABSTRACT TRUNCATED AT 250 WORDS)

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The authors studied psychiatric complications of disulfiram use in 605 alcoholic patients. The subjects were assigned to one of three treatment groups: a 250-mg disulfiram group (N = 202), a 1-mg disulfiram group (N = 204) to control for the fear of the alcohol-disulfiram reaction, and a no-disulfiram group (N = 199) to control for the effect of psychotherapy. No significant differences in the incidence of psychiatric complications were found among the three groups. The authors conclude that if psychiatric complications follow disulfiram use, the incidence must be very low with the doses of disulfiram used presently and in the absence of predisposing factors.

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We conducted a controlled, blinded, multicenter study of disulfiram treatment of alcoholism in 605 men randomly assigned to 250 mg of disulfiram (202 men); 1 mg of disulfiram (204 men), a control for the threat of the disulfiram-ethanol reaction; or no disulfiram (199 men), a control for the counseling that all received. Bimonthly treatment assessments were done for one year. Relative/friend interviews and blood and urine ethanol analyses were used to corroborate patients' reports. There were no significant differences among the groups in total abstinence, time to first drink, employment, or social stability. Among the patients who drank and had a complete set of assessment interviews, those in the 250-mg disulfiram group reported significantly fewer drinking days (49.0 +/- 8.4) than those in the 1-mg (75.4 +/- 11.9) or the no-disulfiram (86.5 +/- 13.6) groups. There was a significant relationship between adherence to drug regimen and complete abstinence in all groups. We conclude that disulfiram may help reduce drinking frequency after relapse, but does not enhance counseling in aiding alcoholic patients to sustain continuous abstinence or delay the resumption of drinking.

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Serum samples from 139 patients with cystic fibrosis (CF) were tested for complement abnormalities and circulating immune complexes (CIC). We found no consistent changes in whole complement activity. However, we found CIC in 29% of these patients and decreased activity of the alternative complement pathway (ACP) in 36%. During 5 yr of observation, mortality was much higher in patients whose sera contained CIC (p less than 0.001) or decreased ACP activity (p less than 0.01). Of patients with both abnormalities, 31% died; however, no deaths occurred in patients with normal ACP activity and negative tests for CIC (p less than 0.001). During a subsequent 2.5-yr period, 55% of patients greater than or equal to 21 yr old with both findings died. In contrast, no deaths occurred in older patients lacking this combination (p = 0.0062). Circulating immune complexes but not decreased ACP activity were an independent risk factor for death. Our findings support the hypothesis that humoral immune mechanisms may contribute to morbidity and mortality in CF.

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Parenteral administration of amino acids has been utilized for the nutritional support of patients with a variety of gastrointestinal disorders including protracted pancreatitis and pancreatic fistulae. However, the effect of parenteral amino acid administration alone on human pancreatic secretion has not been studied. We have studied the short-term effect of parenteral administration of amino acids on pancreatic exocrine secretion in seven healthy men. A double-lumen tube was placed in the duodenum and polyethylene glycol was perfused into the proximal duodenum at the rate of 10 ml/min. A second double-lumen tube was placed in the stomach and bromsulfthalein was perfused into the cardia. Samples of duodenal contents were aspirated and gastric contents recovered during one hour of intravenous saline infusion followed by two hours of an amino acid mixture infusion. Hourly outputs of protein and pancreatic enzymes were determined, correcting for duodenogastric reflux based on concentrations of both markers in the samples. Despite an average increase of 72% in the plasma concentration of the infused amino acids, the outputs of protein, trypsin and amylase did not change significantly during amino acid infusion; the output of lipase decreased significantly during amino acid infusion. Two subjects were given intravenous secretin and cholecystokinin following amino acids; this resulted in increased outputs of protein, trypsin, and amylase in both. We conclude that the parenteral administration of amino acids to healthy young men does not stimulate pancreatic enzyme secretion as measured by the method using duodenal marker perfusion at the rate of 10 ml/min.

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